A Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status

Recruiting now · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

This is an interventional study to explore the efficacy and safety of denosumab combined chemotherapy and anti-PD-1/PD-L1 inhibitor in locally advanced or metastatic NSCLC.

Key facts

Study ID

NCT07034391

Run by

China Medical University, China

People needed

40

Starts

2025-05-12

Expected to finish

2027-10-31

Last updated by the study team

2025-06-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
• Documented negative for EGFR/ALK/ROS1/BRAFV600E/RET/METex14 mutations by validated genomic testing, with no prior targeted therapy and no history of other malignancies
• No previous systemic therapy for advanced/metastatic disease
• At least one measurable lesion per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• No use of parathyroid hormone/derivatives, calcitonin, osteoprotegerin, mithramycin, or potassium supplements within the past 6 months
• Adequate organ and marrow function

You may not qualify if…

• Histologically or cytologically confirmed combined small cell and non-small cell lung cancer (mixed histology)
• Any previous systemic anticancer treatment for NSCLC, including chemotherapy, biologics, immunotherapy, or investigational agents
• Prior use of denosumab or any bone-modifying agents (e.g., bisphosphonates)
• Uncontrolled hypocalcemia or hypophosphatemia
• History or current evidence of osteonecrosis of the jaw (ONJ) or osteomyelitis of the jaw

Where it is running

• The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.